FDA Queries the Public on Menthol

While the FDA is not under any mandate to adopt additional regulations on menthol cigarettes, the agency has reached out to the public for more input on the issue of menthol in cigarettes.

 

In July 2013, the FDA issued a report, “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol vs. Non-Menthol Cigarettes,” that concluded, in part, that menthol cigarettes are not associated with an increase in disease risk vs. non-menthol cigarettes, but may result in a public health impact. As a follow-up to this preliminary scientific report, the FDA’s Center for Tobacco Products issued an advance notice of proposed rulemaking requesting the public’s input on the use of menthol in cigarettes. 

 

In this rulemaking notice, the FDA is asking the public to respond to questions about menthol in cigarettes, many of which require reliance on scientific data and studies. For this reason, NATO and its members have taken the opportunity to provide feedback on several questions posed by the FDA. 

Specifically, the FDA has asked for the public’s input on whether to propose additional restrictions on the sale, distribution, advertising and promotion of menthol cigarettes. 

 

What follows is a summary of NATO’s comments submitted to the FDA, which outline why the FDA should not adopt additional restrictions on menthol and the consequences that such further regulations would have on retailers and the public. 

 

NATO argues that establishing additional restrictions on the retail sale of menthol cigarettes is simply unnecessary. Retailers take the responsibility of selling tobacco products very seriously, and they are not in the business of selling tobacco products to underage youth. This high level of responsibility is evidenced by the FDA’s state compliance inspection program, in which approximately 95% of retailers inspected successfully pass the inspections without any violations, including not selling tobacco products to minors. Given that the FDA’s main goal is to reduce youth access to and use of tobacco products, this high level of vigilance and compliance by retailers demonstrates that there is no need to consider additional retail sales regulations on menthol cigarettes.

 

Rather than impose more regulations, NATO recommends that the FDA should research the phenomenon known as the “enabling adult,” wherein adult-aged friends, family members and even parents obtain cigarettes legally and then provide them to underage youth. With one of the FDA’s primary goals being to reduce youth smoking, addressing the problem of the “enabling adult” and taking action to educate the public that adults should not provide tobacco products to underage youth would likely have a more positive effect on reducing youth smoking than adopting further unwarranted restrictions on the retail sale of menthol cigarettes. In other words, there needs to be a societal attitude change that does not tolerate adults purchasing and providing tobacco products to minors.

 

Moreover, the FDA’s question about establishing more sales restrictions on menthol cigarettes overlooks the numerous regulations already in place on the sale of all cigarettes, including menthol cigarettes. These regulations include: 

 

▶ A minimum legal purchase age of 18;

▶ Age verification of customers younger than 27 years old;

▶ A direct, face-to-face exchange of cigarettes between a store clerk and the customer;

▶ No self-service cigarette displays except in adult-only stores; 

▶ A ban on free samples of cigarettes; and 

▶ A prohibition on the sale of cigarettes in packages of less than 20. 

With these numerous regulations, there is no need to treat the retail sale of menthol cigarettes any differently than non-menthol cigarettes.

 

Regarding potential restrictions on the advertising and promotion of menthol cigarettes, NATO commented to the FDA that the First Amendment to the U.S. Constitution protects free speech and the U.S. Supreme Court has extended these protections to commercial speech, which includes advertising. In fact, the Supreme Court has specifically held that the advertising and promotion of tobacco products are protected as free speech under the First Amendment (see Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 2001). With the advertising and promotion of cigarettes subject to constitutional protections, any proposed restrictions on the advertising and promotion of menthol cigarettes must comply with these constitutional standards. 

 

Section 903(e)(3) of the Family Smoking Prevention and Tobacco Control Act states that the FDA is not limited in its authority to take regulatory action on menthol cigarettes, which means that the agency can ban the use of menthol in cigarettes. However, the question raised by the FDA in the rulemaking notice about banning menthol raises two very different but equally important questions for the FDA to ask itself. 

 

First, why would a government agency that is tasked with protecting the public health consider banning a legal product that will create the right conditions for a black market in menthol cigarettes and, consequently, result in minors having easier access to cigarettes? Second, how is fostering a black market protecting the public from harm when more law enforcement resources will need to be spent fighting organized criminal activity in the illegal trafficking of menthol cigarettes?

 

If the sale of menthol cigarettes is banned in the United States, a black market will emerge for menthol cigarettes. Illicit trade already exists with the transportation and sale of untaxed or low-taxed cigarettes into high-tax states. Similarly, a ban on menthol cigarettes will create the conditions for criminal elements to establish a black market for menthol cigarettes. Government should not be in the business of setting the stage for illegal activity in the pursuit of its regulatory goals.

 

To exacerbate the situation, the criminals dealing in illicit cigarettes will not be concerned with checking photo identification of individuals who desire to buy menthol cigarettes. Rather, the availability of contraband cigarettes to underage youth will undermine the key principle of the Family Smoking Prevention and Tobacco Control Act of reducing youth access to and use of tobacco products. Moreover, banning menthol cigarettes would only force adults who smoke menthol cigarettes to seek out illegal menthol cigarettes on the black market. 

 

Moreover, restrictive regulations or a ban on the sale of menthol cigarettes will severely affect retailers. A ban on menthol cigarettes will result in a significant decline in legal cigarette sales due to customers seeking out black-market menthol cigarettes. This will put more jobs at risk and increase the prospect of retail business closures. The result is lost jobs, lost cigarette tax revenue to state governments and the federal government, and greater expenditures by law enforcement officials to combat what will likely be a widespread black market in menthol cigarettes.

The current FDA tobacco regulations on all cigarettes are more than satisfactory and negate the need to consider additional regulations just on menthol cigarettes. With retailers continuing to do their job to prevent youth access to cigarettes, proposing more restrictive sales and advertising constraints on menthol cigarettes is unnecessary.

 

The deadline to submit comments to the FDA on menthol cigarettes was Nov. 22. After the FDA reviews the comments, the agency will make a determination on whether to issue proposed regulations on the use of menthol in cigarettes. Public comment is allowed again after a government agency issues a proposed set of regulations. There is no specific time by which the FDA needs to finalize regulations on menthol cigarettes and, in fact, the FDA is not required by law to adopt any regulations involving menthol.